title: Oral budesonide for maintenance treatment of collagenous colitis: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  Oral budesonide effectively induces clinical remission in patients with collagenous colitis, a debilitating illness characterized by chronic watery/loose diarrhea, but there is a high rate of relapse after treatment cessation.
  
  
  METHODS
  This randomized, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of long-term therapy with oral budesonide (Entocort CIR capsules) for maintenance of clinical remission of collagenous colitis. Patients were aged >18 years with histologically proven collagenous colitis and >3 watery/loose stools per day on >or=4 of the prior 7 days. Open-label oral budesonide 9 mg/d was administered to all patients for 6 weeks. Patients in clinical remission (<or=3 stools per day) at week 6 were subsequently randomized to double-blind oral treatment with budesonide 6 mg/d or matching placebo for 6 months. Relapse was defined as >3 stools per day on >or=4 consecutive days (and included patients withdrawn because of adverse events).
  
  
  RESULTS
  Of 48 enrolled patients, 46 (96%) achieved clinical remission at week 6 and were randomized to maintenance budesonide or placebo. There were 21 relapses during maintenance therapy, and almost all occurred during the first 2 months. Budesonide therapy was associated with a significantly lower cumulative rate of relapse compared with placebo (6/23 [26%] and 15/23 [65%], respectively; P = .022), and high correlation between clinical remission and histologic improvement was observed. Budesonide was well tolerated with no serious adverse events.
  
  
  CONCLUSIONS
  Oral budesonide 6 mg/d is efficacious and well tolerated for long-term maintenance of clinical remission in patients with collagenous colitis.
authors.affiliation: Medical Department I, Technical University Hospital, Dresden, Germany. Stephan.Miehlke@uniklinikum-dresden.de
authors.forename: Stephan
authors.initials: S
authors.lastname: Miehlke
authors.forename: Ahmed
authors.initials: A
authors.lastname: Madisch
authors.forename: Birgit
authors.initials: B
authors.lastname: Bethke
authors.forename: Andrea
authors.initials: A
authors.lastname: Morgner
authors.forename: Eberhard
authors.initials: E
authors.lastname: Kuhlisch
authors.forename: Christine
authors.initials: C
authors.lastname: Henker
authors.forename: Gerfried
authors.initials: G
authors.lastname: Vogel
authors.forename: Matthias
authors.initials: M
authors.lastname: Andersen
authors.forename: Eberhard
authors.initials: E
authors.lastname: Meier
authors.forename: Gustavo
authors.initials: G
authors.lastname: Baretton
authors.forename: Manfred
authors.initials: M
authors.lastname: Stolte
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D001706:Biopsy; D019819:Budesonide / Q000008:administration & dosage*; D046729:Colitis, Collagenous / Q000175:diagnosis / Q000188:drug therapy*; D003113:Colonoscopy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007413:Intestinal Mucosa / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012074:Remission Induction; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D019819:Budesonide